Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Filing Overview topic
No spam. Unsubscribe anytime.
Agency official outlines common ANDA filing deficiencies and how to avoid them
Summary
An agency official summarized what constitutes major deficiencies, typical stumbling blocks across eCTD modules, and urged applicants to include justifications in the original ANDA submission to avoid refuse-to-receive decisions or information requests.
An agency official opened the briefing by defining the filing-review objective: determine whether an Abbreviated New Drug Application (ANDA) is substantially complete so it can receive a substantive review. The official said the division aims "to file substantially complete ANDAs" while maintaining uniform review standards and minimizing information requests.
The presentation defined three outcomes applicants should understand: a major deficiency that can lead to a refuse-to-receive (RTR); a stumbling block that impedes filing and can escalate into a major deficiency or information request; and an information request where reviewers ask for clarification or evidence that the data were in the original submission. The official emphasized applicants should provide justifications "in the ANDA as originally submitted to be substantially complete."
